Bladder Irritation and UTI
Bladder Irritation and UTI is an FDA drug label for the active ingredient CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI manufactured by HomeoCare Laboratories, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20190319.
- Generic name
- CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI
- Manufacturer
- HomeoCare Laboratories, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 61727-353
- Application
- N/A
- Label effective
- 20190319
About this product
Bladder Irritation and UTI is an FDA-registered drug product whose active ingredient is CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI. It is labelled by HomeoCare Laboratories, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 61727-353, label effective 20190319. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI are most often described in connection with: temporarily relieves, burning sensation, frequent urge, urinate painful, urination inflammation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses* Temporarily relieves burning sensation frequent urge to urinate painful urination inflammation
Dosage & Administration
Directions: Adult and children 12 years and older: Under 12 consult a doctor. Slightly chew one tablet and allow to dissolve in the mouth, 3 times daily or up to 6 times daily for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve. Take at least 15mn apart from food and drinks
Warnings
Warnings If pregnant or breastfeeding , ask a health professional before use. Stop use and ask a doctor if symptoms persist, worsen or reoccur, are severe, or if you experience fever, chills, back pain or bloody urine. Keep this and all medicinces out of the reach of children.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0609-2024 | STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01 | Homeocare Laboratories, Inc. | Class I | Terminated | 20240724 |
| D-0610-2024 | STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16 | Homeocare Laboratories, Inc. | Class II | Terminated | 20240724 |
| D-0883-2023 | Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01 | Homeocare Laboratories, Inc. | Class II | Terminated | 20230705 |
| D-0890-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01 | Homeocare Laboratories, Inc. | Class II | Terminated | 20230705 |
| D-0885-2023 | SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 | Homeocare Laboratories, Inc. | Class II | Terminated | 20230705 |
Frequently asked questions
What is Bladder Irritation and UTI used for?
Uses* Temporarily relieves burning sensation frequent urge to urinate painful urination inflammation
Who makes Bladder Irritation and UTI?
HomeoCare Laboratories, Inc. is the labeler of record for Bladder Irritation and UTI.
What form does Bladder Irritation and UTI come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Bladder Irritation and UTI prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Bladder Irritation and UTI been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.